Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
April 27, 2022 updated by: Yehuda Ullmann MD, Rambam Health Care Campus
The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
During pressure injuries formation early sub dermal bio signal appear.
By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Rambam healrh care campus
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with stage 1 pressure injury
- Patients with high risk of developing pressure injury
Exclusion Criteria:
- Patients with stage 2 pressure injury or higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Suspected pressure injury
Patients evaluated with high-risk for pressure injury
|
Infrared spectroscopy device will be used to detect non-visible pressure injuries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early detection of pressure induced tissue damage
Time Frame: Ten minutes
|
Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury
|
Ten minutes
|
|
Pressure injury probability
Time Frame: Ten minutes
|
Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days
|
Ten minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2018
Primary Completion (Actual)
May 12, 2021
Study Completion (Actual)
May 12, 2021
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
April 25, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2022
Last Update Submitted That Met QC Criteria
April 27, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0039-18-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.